Phase 2 Study of Vinblastine in Children With Recurrent or Refractory Low Grade Glioma

NCT00213278 | Completed Phase 2 DMC

• 1 other identifier: 0020010429
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study is examining whether Vinblastine is an effective drug to shrink low grade glioma brain tumors in children, and what the side effects are.

Conditions

Glioma

Keywords

glioma; brain tumour; cancer; pediatrics; vinblastine sulfate

Outcome Measures

Primary Outcomes (1)

• To determine the response rate to Vinblastine in recurrent low grade glioma of childhood

  52 weeks

Secondary Outcomes (1)

• To further assess the toxicity of weekly vinblastine in children treated at the currently defined maximally tolerated dose (MTD) of Vinblastine

  52 weeks

Study Arms (1)

1

EXPERIMENTAL

Drug: vinblastine sulphate injection

Interventions

vinblastine sulphate injection DRUG

Vinblastine dose: 6 mg/m\^2 (10 mg max.) route intravenous administration once a week over a period of 10 weeks. If response at week 10 is greater than or equal to stable, weekly Vinblastine will be continued for 42 weeks.

1

Eligibility Criteria

• Age: 1 Day - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \< 21 years of age at original diagnosis
• histological verification of low grade glioma (glial tumors, neuronal tumors or chiasmatic-hypothalamic tumor) at original diagnosis
• evidence of tumor recurrence or progression by MRI or contrast CT
• Karnofsky and Lansky performance status of 0,1 or 2
• life expectancy of greater than or equal to 2 months
• adequate organ and bone marrow function within 7 days of starting treatment with Vinblastine
• absolute neutrophil count (ANC)\> 1000/uL
• platelet count \> 100,000/uL (transfusion independent)
• serum creatinine \< 1.5 x normal for age
• written informed consent signed by subject and/or subject's parent/legal guardian

You may not qualify if:

• not recovered from the acute toxic effects of all prior chemotherapy, immunotherapy or radiotherapy
• chemotherapy within 2 weeks of entry in study (4 weeks if prior nitrosourea was used)
• less than 7 days since the completion of therapy with a biologic agent
• less than 2 months since cranial/spinal radiation
• receiving a stable dose of dexamethasone for less than one week

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Ontario Cancer Research Network: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Glioma; Brain Neoplasms; Neoplasms

Interventions

Vinblastine

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Eric Bouffet, MD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Head, Neuro-Oncology

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: January 1, 2002
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2012
• Last Updated: November 20, 2014

Record last verified: 2014-11

Locations

CA (1)